Russell Oakley is recruiting for a Snr Associate/Associate TMF Management & Compliance in Global Regulatory Affairs (GRO) to join a Pharmacuetical company at their site based in Hertfordshire on a permanent basis.

The TMF Associate/Sr Associate is responsible for performing daily support activities ensuring the integrity of the Trial Master File (TMF). Functions include: Coordinating TMF set-up and maintenance; Archiving of TMFs; Assisting with the oversight of the eTMF vendor and business process; eTMF query resolution, eTMF user support and training; Performing quality control (QC) review of study TMFs to ensure they are of the highest quality and inspection ready, adhere to SOPs, and meet compliance specifications according to regulatory requirements and ICH guidelines.

This role will be required to work collaboratively across functional areas and contribute to positive team relationships, both locally and globally.The Sr Associate, TMF Management and Compliance, will lead initiatives and will serve as a subject matter expert in TMF Management

Further responsibilities will include:Lead various TMF activities associated with TMF Management, including TMF setup, eTMF query resolution, eTMF user support and training. Assist with developing training materials and conducting TMF training for global eTMF users; assist with managing the activities of TMF associate and/or contract staffPerform the activities associated with quality control reviews of study TMFs to ensure adherence to SOPs and regulatory requirements and that the TMF is inspection ready. These activities include: preparing the Study QC Review Plan and conducting associated risk assessments; perform QC reviews; prepare QC Findings reports; assist with analyzing trends and preparing metrics; Provide feedback to project teams and /or management for the correction and resolution of document quality issues, TMF completeness and timely submission of documents to the TMF;Assist with oversight of the eTMF vendor to ensure service meets expectations; interact with eTMF vendor, company functional areas, and/or CROs to resolve eTMF queries, issues and questions related to the eTMF business process; collaborate with study teams to monitor the eTMFs for completeness and qualityCoordinate the activities related to archiving of TMF documents, including obtaining approval from the study team, notifying the eTMF vendor, and maintaining electronic logs which contain the location of study documents. Oversee the shipping, retrieval and tracking of documents approved for archiving to off-site storage; Assist with maintaining and updating the TMF file structure and business rules; conduct continuous improvement and monitoring of the business environment to anticipate future areas of risk and need for process changes; collect and evaluate recommendations for improvement from the user community. Facilitate the writing or update of departmental SOPs and SWPs as needed; initiate improvements to departmental SOPs and SWPs.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:Education to BSc level or equivalent, preferably in a scientific disciplineStrong background in the pharmaceutical industry, preferably in regulatory operations or clinical development/operationsDemonstrated experience with Clinical Document Management, TMF/eTMF, and/or Clinical Quality Control desiredMust have strong document management skills, including experience with review of regulatory documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlinesMust have strong knowledge of and be able to differentiate all key clinical trial essential documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents).Must have good understanding of the clinical development process, including regulatory documents and regulatory requirements (including ICH and GCP guidelines)Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41252 in all correspondence.